Kornimate/medical-research-clean huggingface dataset:
auditory steady state response vsauditory brainstem response

Conditions: Hearing Impaired Children

Summary: all children with hearing loss should have access to resources necessary to reach their maximum potential. the following principles provide the foundation for effective ehdi\[early hearing detection \& intervention\] systems and have been updated and expanded since the 2000 jcih \[ joint committee on infant hearing \] position statement .

1. all infants should have access to hearing screening using a physiologic measure at no later than 1 month of age. 2. all infants who do not pass the initial hearing screening and the subsequent rescreening should have appropriate audiological and medical evaluations to confirm the presence of hearing loss at no later than 3 months of age. 3. all infants with confirmed permanent hearing loss should receive early intervention services as soon as possible after diagnosis but at no later than 6 months of age. a simplified, single point of entry into an intervention system that is appropriate for children with hearing loss is optimal. the importance of early identification and habilitation of hearing loss for improved access to auditory stimuli and for positive prognosis of speech and language is well established in the literature . auditory brain stem response (abr) is the most commonlly used test in clinical practice to estimate the degree of hearing loss, but the auditory brainstem response (abr) cannot differentiate between severe and profound snhl \[5\], whereas the assr can provide threshold information in a frequency-specific manner at intensity levels of 120 db and higher. this intensity stimulation advantage uniquely qualifies the assr for investigation of residual hearing in young and difficult-to-test cochlear implant candidates.

Eligibility criteria:
inclusion criteria: * absent abr \[auditory breanstem response\] waves . * normal middle ear function exclusion criteria: * ears with otitis media with effusion, * preserved otoacuastic emission , * preserved abr waves .

Keywords: hearing loss
thalamic deep brain stimulation for tourette syndrome

Conditions: Tourette Syndrome

Summary: in this single-center trial, we aim to include 8 patients with severe and medically refractory tourette's syndrome. all patients undergo deep brain stimulation surgery with two electrodes located in the centromedian-parafascicular complex. tic severity and secondary outcome measurements are assessed six and twelve months after surgery. additionally, a short randomized, double-blinded sham controlled crossover sequence of 24 to 48 hours in either active or sham stimulation is implemented after both 6 and 12 months assesments. subjects and clinicians are blinded to treatment allocation.


Eligibility criteria:
inclusion criteria: * das tourette-syndrom (icd-10: f 95.2; dsm iv: 307.23) als hauptdiagnose. bei dem patienten ist aufgrund einer chronischen, schwergradigen und therapieresistenten verlaufsform des ts eine behandlung mittels ths thalamischer strukturen im sinne einer ultima ratio vorgesehen. * alter des patienten 18 bis 65 jahre * sicher im verstehen der deutschen sprache * unterzeichnete einverständniserklärung exclusion criteria: * klinisch manifeste psychose * schwangerschaft und stillzeit * unterbringung nach psychkg * kontraindikationen einer mrt-untersuchung wie z. b. implantierter herzschrittmacher / defibrillator * neoplastische neurologische erkrankungen * kontraindikationen einer stereotaktischen operation, wie z. b.: erhöhte blutungsneigung, cerebrovaskuläre erkrankungen (z. b. arteriovenöse malformationen, aneurysmata, systemische gefäßerkrankungen, die auf das cerebrum übergreifen). * teilnahme an einer anderen klinischen studie * hirnassoziierte kriterien, die eine op ausschließen (gefäßanomalien, große arteriovenöse malformationen, hirnmetastasen, neoplasien des zns (ausnahme asymptomatisches inzidentielles meningeom)) * antikoagulationtherapie, die in der perioperativen phase nicht ausgesetzt werden kann * op am gehirn in der anamnese, die mit der platzierung/funktion des mp interferieren * med. gegebenheiten, die mit der studienprozedur interferieren oder evaluation der studienparameter beeinträchtigen inkl. erkrankungen im terminalen stadium (lebenserwartung \< 12 monate) * akute suizidalität * abhängigkeit von alkohol oder drogen (exklusive cannabis, da es von schwer betroffenen patienten teilweise zur ticreduktion im sinne einer selbstmedikation eingesetzt wird sowie exklusive opioide und benzodiazepine, wenn diese initial zur ticreduktion im sinne einer selbstmedikation eingesetzt wurden) * klinisch relevante internistische oder neurologische erkrankungen * intelligenzminderung * alle aktiv implantierten medizinprodukte * schweres schädel-hirn-trauma in der anamnese * metallimplantate im kopfbereich ( bsp. aneurysmaclips)
a comparison of insulin drip protocols in labor: a randomized trial

Conditions: Diabetes; Pregnancy

Summary: to assess which of two commonly utilized insulin drip protocols has better outcomes when used during the labor process.


Eligibility criteria:
inclusion criteria: * a. pregnant patients with either pre-existing diabetes or gestational diabetes type a2 who require insulin for euglycemia during labor and delivery exclusion criteria: * a. those patients who decline participation * b. patients less than age 18 at the time of enrollment will be excluded to protect this vulnerable patient population c. those patients who cannot be consented d. patients scheduled for cesarean delivery

Keywords: insulin drip labor
ambulatory blood pressure monitoring in hypertension

Conditions: Hypertension

Summary: the primary objective of this proposal is to demonstrate that abpm can be used to improve study design for interventional trials in children with hypertension.

abpm is a standard technique in adult antihypertensive trials to study the magnitude and duration of effect of investigational drugs. these methods are needed for pediatric studies. before such methods can be developed, preliminary information must be collected to demonstrate that the device can be used for antihypertensive studies in children (i.e, to determine the dropout rate following the first abp study, to determine the frequency of white coat hypertension in a selected population, to compare casual (office) blood pressures commonly used to diagnose hypertension in children with those obtained by abpm, and to assess the placebo effect in children with borderline and mild hypertension). all participants will be asked to complete 24 hour abpm on two occasions within one week. during the abpm parents and children will be asked to keep a diary recording the times that the child slept. a crossover design will be used, where subjects are initially randomized to either drug or placebo and then will be crossed over to the other intervention at a set time during the study.

Eligibility criteria:
inclusion criteria: * male and female children 5-16 years of age. * borderline or mild systolic and or diastolic hypertension as defined by 1996 task force criteria. * no current drug therapy for hypertension being taken. * must be ambulatory and willing to wear an abp monitor for 24 hours * agree to refrain from swimming, showering and other activities that might result in damage to abp monitor during the two 24 hour intervals that the monitor is worn. * standing height between 45 inches and 73 inches * informed parental consent and patient assent. exclusion criteria: * severe or life threatening hypertension. * any drug therapy that may raise or lower the blood pressure. * any severe bleeding disorder or concurrent treatment with anticoagulant medications * non-ambulatory * significant arrhythmia * previous history of significant non-compliance with prescribed medical care. * any other disease that, in the opinion of the investigator, might interfere with the accurate measurement of the blood pressure or place the subject at risk unnecessarily.

Keywords: hypertension abpm ambulatory blood pressure monitoring
ultrapower; a minimally invasive tool for evaluation of total cardiac power

Conditions: Cardiac Diseases

Summary: the heart is essentially a hydraulic pump which ensures adequate delivery of blood through generating pressure and forward flow of blood. the energy delivered by the heart is uncommonly measured clinically, and todays gold standard involves placing a plastic catheter into the lung arteries. the investigators have developed an ultrasound based approach to calculate this energy without the need for catheters through the heart. this novel approach is called ultrapower. ultrapower involves the instantaneous multiplication of the cardiac output and the arterial blood pressure. the study aims to use the ultrasound based approach to investigate cardiac power in the coronary artery bypass graft population.


Eligibility criteria:
inclusion criteria: • coronary artery bypass graft operation exclusion criteria: * lack of informed consent * previous aortic valve replacement * inadequate doppler signal on transthoracic echocardiography

Keywords: hemodynamics echocardiography, doppler, pulsed
combining manual soft tissue release and exercise training in copd: the effect on lf, ec, and caf

Conditions: Chronic Obstructive Pulmonary Disease; Manual Soft Tissue Release; Exercise Training; Lung Function; Exercise Capacity; Cardiac Autonomic Function

Summary: the potential effects of combining manual soft tissue release and physical exercise training on lung function, exercise capacity, and cardiac autonomic function in patients with moderate and severe chronic obstructive pulmonary disease were investigated.

chronic obstructive pulmonary disease (copd) commonly presents with accessory respiratory muscle tightness and weakness, affecting chest wall compliance and lung elasticity. however, traditional physical therapy interventions, including pursed-lip breathing, sputum clearance techniques, and respiratory muscle training, are often used in treatment guidelines, with few studies focusing on muscle release for the accessory respiratory muscles. although the effects of manual therapy on lung function and chest tightness in copd have been demonstrated, the effects of soft tissue release combined with exercise intervention on copd, including lung function, exercise capacity, and cardiac autonomic function, remain unknown. therefore, this study proposes a randomized controlled trial to investigate the effects of manual soft tissue release combined with exercise training on lung function, exercise capacity, and cardiac autonomic function in patients with copd. it is expected that the results of this study will demonstrate that combining manual soft tissue release with exercise training may increase gas exchange in the lungs, reduce respiratory effort, improve co-morbidities, delay disease progression, and enhance patient quality of life and clinical intervention.

Eligibility criteria:
inclusion criteria: * gold grade ii\~iv * stable condition * no acute exacerbations in 6 weeks exclusion criteria: * acute heart failure and, or arrhythmia * pulmonary arterial hypertension * skeletal and, or neuromuscular disorders * chest surgery * untreated or uncontrolled conditions * rheumatoid conditions * depends on oxygen supply

Keywords: chronic obstructive pulmonary disease manual soft tissue release exercise training lung function exercise capacity cardiac autonomic function pulmonary rehabilitation
an intervention to enhance well-being in trauma exposed new mothers

Conditions: Post-traumatic Stress Disorder; Dissociation; Maternal Care Patterns; Infant Behavior; Maternal Behavior; Maternal Distress; Mood Disturbance; Emotional Regulation

Summary: this pilot randomized controlled trial will evaluate the feasibility and effectiveness of a mobile neurofeedback intervention for increasing maternal overall well-being, and measuring whether mothers experience any subsequent reductions in trauma symptoms and parenting stress and enhancements in regard to emotional regulation, parenting sensitivity and positive parenting behaviors, as well as infant socio-emotional development and behavioral outcomes (i.e., crying, fussing) among postpartum mothers with symptoms of post-traumatic stress disorder. the investigators hypothesize that mothers who receive the neurofeedback intervention will demonstrate larger decreases in mental health symptoms, greater improvements in emotional regulation and observed parenting behaviors, increased feelings of parenting competency, decreased feelings of parenting stress, and reductions in the potential for child maltreatment than mothers in the control group. the investigators also hypothesize that infants of mothers who receive the neurofeedback intervention will demonstrate less crying and fussiness and higher scores on socio-emotional developmental assessments than infants of mothers in the control group at the posttest interval.


Eligibility criteria:
inclusion criteria: * the inclusion criteria for mothers will be 1) a score of 2+ on the adverse childhood experiences measure for childhood trauma exposure; 2) a score of 3+ on the primary care ptsd screen for dsm-5 (pc-ptsd-5) screening measure for ptsd symptoms or endorsement of 2 or more past-month symptoms of moderate or greater severity on the depersonalization/derealization subscale of the dissociative subtype of ptsd scale (dsps); 3) having a child who is between the ages of 3-9 months old; 3) having a personal phone or tablet device that is compatible with the muse 2 neurofeedback device. exclusion criteria: * mothers and their infants will be excluded if mothers 1) have a lifetime history of significant untreated mental illness, neurological or pervasive developmental disorders; 2) have a documented history of epilepsy; 3) ever experienced previous head injury with loss of consciousness; 4) are currently experiencing intimate partner violence or otherwise state that their current living conditions are unsafe; 5) are currently experiencing psychosis or have been suicidal within the last six months; 6) are currently taking, or in the past month have taken benzodiazepines, narcotic drugs, or cannabis; 7) have engaged in self-harming behaviors in the last 3 months requiring medical attention; 8) are pregnant; 9) are current students at wayne state university or have plans to enroll as a student at wayne state university anytime in the next 12 months; 10) do not have competence to understand or consent/assent to the study procedures; or 11) do not have fluency in written and spoken english.
stylistic memory enhancement

Conditions: Multiple Sclerosis

Summary: impairments in higher level cognitive processing, such as new learning and memory, are common in multiple sclerosis (ms) and negatively impact multiple aspects of everyday life, including occupational and social functioning. despite this, few studies have attempted to remediate these cognitive deficits in order to improve everyday functioning. while not applied in traditional rehabilitation protocols as of yet, many techniques from cognitive psychology significantly improve learning and memory in healthy persons. these techniques include the generation effect (ge), the spacing effect (se), and the testing effect (te). these techniques have recently been incorporated into an 8-session treatment protocol, stylistic memory enhancement (sme), designed to teach participants about each of the techniques, train them on how to apply the techniques in daily life and practice their application to daily life memory demanding situations. the protocol includes teaching participants how to restructure a memory demanding situation in order to make optimal use of self-generation, spaced learning and self-testing. the objective of the study is to test the efficacy of the sme in an ms population.


Eligibility criteria:
inclusion criteria: clinically definite ms between the ages of 18 and 59. participants must have impairment in new learning (determined by an in-person screen) with intact language comprehension. exclusion criteria: * history of alcohol or drug abuse/dependence, * major psychiatric disturbance (e.g. bipolar disorder, schizophrenia) and neurological history other than ms. * corticosteroid use within the last month prior to the participation. * less than 1 month post most recent exacerbation.

Keywords: memory cognition
study of brentuximab vedotin in participants with relapsed or refractory systemic anaplastic large cell lymphoma

Conditions: Lymphoma

Summary: the purpose of this study is to assess the antitumor efficacy of single-agent brentuximab vedotin 1.8 mg/kg administered intravenously (iv) every 3 weeks, as measured by the overall objective response rate (orr) in patients with r/r salcl following at least 1 multiagent chemotherapy regimen (cyclophosphamide, doxorubicin hydrochloride \[hydroxydaunorubicin\], vincristine sulfate \[oncovin\], and prednisone \[chop\] or equivalent multiagent chemotherapy regimens with curative intent).


Eligibility criteria:
inclusion criteria: * male or female participants age 18 years or older, with relapsed or refractory salcl who have previously received at least 1 multiagent chemotherapy * bidimensional measurable disease * an eastern cooperative oncology group (ecog) performance status of 0 or 1 * female participants who are postmenopausal for at least 1 year before the screening visit, surgically sterile, or agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 30 days after the last dose of study drug, or agree to practice true abstinence * male participants who agree to practice effective barrier contraception during the entire study treatment period through 6 months after the last dose of study drug or agree to practice true abstinence * clinical laboratory values as specified in the study protocol exclusion criteria: * previous treatment with brentuximab vedotin. * previously received an allogeneic transplant. * participants with current diagnosis of primary cutaneous anaplastic large cell lymphoma \[alcl\] (participants whose alcl has transformed to salcl are eligible). * known cerebral/meningeal disease including signs or symptoms of progressive multifocal leukoencephalopathy (pml) * female participants who are lactating and breastfeeding or pregnant * known human immunodeficiency virus (hiv) positive * known hepatitis b surface antigen-positive, or known or suspected active hepatitis c infection

Keywords: lymphoma anaplastic large-cell relapsed refractory antigens, cd30 antibody-drug conjugate antibodies, monoclonal lymphoma, non-hodgkin lymphoma, large-cell, anaplastic monomethyl auristatin e drug therapy immunotherapy hematologic diseases
effect of 4 weeks of oral d. piger on safety, pharmacokinetics and ethanol metabolism in overweight individuals (2023)

Conditions: Obesity; Metabolic Syndrome; Steatosis of Liver

Summary: the goal of the study is to determine the effect of supplementation of the d piger strain on intestinal ethanol production in individuals with overweight. the investigators will perform a randomized trial in 2x10 participants to measure effects on ethanol in blood, and perform fecal analyses.

the investigators perform a randomized, placebo controlled trial in 2x10 participants. the participants will be given placebo or d piger as an oral suspension once daily for 30 days. at baseline and after 30 days, a fructose challenge test with fomepizole, gastroduodenoscopy and mri liver + fibroscan will be performed. patient will attend the clinical trial unit weekly for safety visits. the participants will be overweight males or females age 18-70 with impaired glucose tolerance.

Eligibility criteria:
inclusion: male or (postmenopausal) females * increased waist circumference (\>102 cm men, 88\>cm women) * insulin resistance (homa\>2.5) * 18-70 years exclusion criteria: * use of systemic medication (except for paracetamol), including antibiotics and pro-/prebiotics in the past three months or during the study period. * a history of a cardiovascular event * a history of cholecystectomy * overt untreated gastrointestinal disease or abnormal bowel habits * liver enzymes\>2.5 fold higher than the upper limit of normal range * smoking * alcohol abuse
blood concentration in lorazepam and treatment in adult catatonia

Conditions: Catatonia

Summary: catatonia is a severe form of psychomotor disturbance with a heterogenous presentation. it affects approximately 10% of acute psychiatric inpatients. according to the fifth edition of dsm-5 the diagnosis of catatonia can be made when three or more symptoms from the twelve following are present : catalepsy, waxy flexibility, stupor, agitation, mutism, negativism, posturing, mannerisms, stereotypies, grimacing, echolalia, echopraxia. it can occur in various psychiatric diseases, including mood disorders or schizophrenia, but also in various non-psychiatric disorders \[metabolic disturbances, viral infections (including hiv), typhoid fever, heat stroke, and autoimmune disease\]. benzodiazepines, especially lorazepam, are the most common initial treatment, with a remission rate of approximately 70-80 %, regardless of the cause or the clinical manifestations. this first line treatment is titrated gradually according to the therapeutic response over a few days up to 20-25 mg per day. electroconvulsive therapy (ect) is initiated on patients with catatonia who do not respond to benzodiazepines. interestingly, pharmacogenetic variants can alter the metabolism of lorazepam (e.g., the ugt2b15 \* 2 allele slows it down). the main objective of this study is to assess the link between clinical response to lorazepam, residual plasma concentrations of lorazepam after 72 hours of fixed dosage, and the existence of genetic polymorphisms modifying the metabolism of lorazepam. our hypothesis is that non-responding patients have lowered blood concentrations of lorazepam associated to a genetic profile of rapid metabolism. evaluating the predictive factors of the response to treatment would allow early and precise identification of non-responder patients in order to adapt their first-line treatment.


Eligibility criteria:
inclusion criteria: * catatonia according dsm-5 exclusion criteria: * subject is less than 18 years of age * subject is pregnant at the time of the study * subject/legal guardian unwilling to participate in the study
pre-mix insulin lispro treatment for type 2 diabetes patients who consume a light breakfast

Conditions: Diabetes Mellitus, Type 2

Summary: this study is designed to look at how best to start and then gradually intensify (as needed) the insulin lispro premix regimen in type 2 diabetes patients who consume a light breakfast.


Eligibility criteria:
inclusion criteria: * diabetes mellitus, type 2 * have been receiving metformin plus at least one other oral antihyperglycemic medication (oam) (sulfonylurea or thiazolidinedione \[tzd\]) without insulin, for at least 90 days prior to visit 1 * glycosylated hemoglobin (hba1c) greater than or equal to 7.0% and less than 11.0% * regularly consume a light breakfast (less than 15% of total daily calorie intake) * capable and willing to follow the protocol * give written consent exclusion criteria: * are taking a tzd whose country label does not allow in combination with insulin * are taking any glucose-lowering agents (other than specified in the inclusion criteria above) * have a body mass index greater than 40 kg/m\^2 * have a history of severe hypoglycemia in past 24 weeks * are pregnant or may become pregnant * women who are breastfeeding * have significant cardiac disease * have significant renal or liver disease * undergoing therapy for a malignancy * contraindications to study medications * have an irregular sleep/wake cycle